Job Code: 081
Oversee the day-to-day operation of CDI?s manufacture facility for iPSC derivation at the Buck Institute in CA. Manage the operation to generate over 9000 iPSC lines as part of a grant from the California Institute for Regenerative Medicine.
Skills and Responsibilities:
(Note: Objective evidence of qualification or training completion is required for these skills.)
Provides technical and managerial leadership in manufacturing iPSCs.
Sets manufacturing and in/ out bound logistics strategies to ensure attainment of financial and strategic goals, and resource requirements.
Material management including reagents, starting tissue materials and inventory management
Routine work with data management systems such as LIMS.
Develops and encourages best practices for operational excellence and continuous improvement within the manufacturing function and with all cross functional interfaces -measuring and driving performance of manufacturing-based KPI?s.
Ensures that standards for product quality, manufacturing costs and throughput, equipment and operator performance, employee safety and housekeeping standards are maintained.
Facilitates decision-making, resolves conflicts and builds/optimizes cross-functional team efforts to assure that all manufacturing and departmental objectives are met.
Oversees planning, execution and compliance of the Production budget including expense, capital and inventory budgets.
Maintains ongoing analysis of key issues, projects, and objectives, and provides regular reports that include metrics to summarize the status and trends of key operational parameters.
Reviews needs and provides training opportunities for staff to develop personal job-related skills and to improve operational flexibility in accordance with strategic needs.
Works actively on gross margin improvement through annually planned COGS reduction.
Actively fosters an environment of continuous improvement among all employees.
Ensures fixed assets and facilities are preserved using best maintenance practices.
Develops departmental goals that support the strategic goals of CDI.
Works to improve inventory levels.
Ensures compliance with applicable quality management system.
Ensures compliance with state and federal environmental and safety regulations.
Enforce adherence to quality standards regarding the acceptance of incoming biological materials and work with tissue providers as needed.
Understands and complies with ethical, legal and regulatory requirements applicable to CDI.
Qualifications:
Master of Science in life sciences or a technical field such as engineering.
A clear understanding of process needs for large-scale manufacture of cell lines using automated equipment.
Minimum 8 years management experience in a technical area within a cross-functional team environment.
Proficiency with data management systems such as LIMS.
Must have excellent communication skills.
Strong organizational skills.
Expertise in gated process life cycle management.
Quality Management Systems expertise (such as TQM, Lean manufacturing, Six Sigma).
Proficient in MS Office and ERP systems.
Experience in manufacturing human iPS or ES cell-derived cell types for the life science industry.
Strong organizational and communication skills and a demonstrated ability and desire to share experience and knowledge with staff.
Integrated view of the technical, financial and quality aspects of the areas of responsibility.
Physical Requirements:
Able to work at computer for extended periods of time.
Able to wear standard laboratory PPE.
Able to occasionally lift 50 pounds.
Able to safely handle hazardous materials.
Ability to travel as needed.